LIPS-B: Lung Injury Prevention Study With Budesonide and Beta

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

— LIPS-B  

Official title:

LIPS-B: Lung Injury Prevention Study With Budesonide and Beta Agonist (Formoterol)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01783821
• Other study ID #: 12-008192
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 31, 2013
• Last updated: July 6, 2015
• Start date: July 2013
• Est. completion date: January 2016

Study information

• Verified date: July 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

THE STUDY WILL ANSWER WHETHER INHALED BUDESONIDE AND FORMOTEROL ARE ABLE TO ALLEVIATE OR PREVENT PULMONARY INJURY WHEN ADMINISTERED EARLY IN HOSPITAL COURSE TO THE PATIENTS AT RISK FOR DEVELOPING ARDS

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (age > 18);

• Admitted to the hospital through the emergency department (ED);

• High risk of developing ARDS (Lung Injury Prediction Score-LIPS greater than or equal to four;

Exclusion Criteria:

• Inhaled corticosteroid and/or beta agonist treatment on admission or within 7 days prior to admission (history of asthma or COPD necessitating therapy)

• Chronic pulmonary disease requiring daytime oxygen supplementation therapy

• Systemic steroid treatment on admission or within 7 days prior to admission equivalent to more than 5 mg of prednisone daily

• Inability to obtain consent within 12 hours of hospital presentation

• Acute lung injury prior to randomization

• Receiving mechanical ventilation before current hospital admission (patient who is ventilator dependent)

• Presentation believed to be purely due to heart failure without other known risk factors for ARDS

• Allergy or other contraindication to either budesonide and/or formoterol use

• Expected hospital stay and/or survival <48 hours or admission for comfort or hospice care

• Patient, surrogate or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)

• Previous enrollment in this trial.

• Co-enrollment with LIPS-A trial is not allowed.

• An active enrollment in other concomitant trial will be judged on case by case basis by PIs of both trials.

• EKG and/or clinical presentation suggestive of acute coronary ischemia

• New onset cardiac arrhythmia

• Current atrial fibrillation with ventricular rate of >110/minute

• Persistent sinus tachycardia of >130/minute despite early goal directed therapy with fluids, pressors, antibiotics and supplemental oxygen Pregnant patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Drug:
• Budesonide and formoterol
Patients randomized to one of two intervention arms, will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) every 12 hours, for 5 days or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
• Placebo

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	Boston	Massachusetts
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Stanford University	Stanford	California
United States	University of Arizona	Tucson	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	Beth Israel Deaconess Medical Center, Stanford University, University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in oxygen saturation to fraction of inspired oxygen concentration (S/F) ratio		Change in S/F ratio from baseline to day 5 after the first treatment	No